Principal Biomarker Biostatistician

About the job

Our Hubs are a crucial part of how we innovate, improving performance across Sanofi departments and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Principal Biomarker Biostatistician within our Statistics Team at Hyderabad, you will play a crucial role in developing and implementing different statistical and machine learning algorithms to solve complex problems and support our clinical biomarker data insights generation. You will work closely with cross-functional teams to ensure data is accessible, reliable, and optimized for analysis. Your expertise in omics data, machine learning and deep learning will be essential in driving our data initiatives forward.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

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  Provide high quality input regarding TM/Biomarker aspects into the design of the clinical study (including protocol development), the setup of the study to make sure biomarker data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses under guidance of project biomarker statistical lead.

• Coordinate the activities of external partners and CROs for biomarker data generation, dataflow or biomarker statistical activities

• Perform pre-processing and normalization of biomarker data (e.g., RNAseq, scRNAseq, Olink, flow cytometry data etc.)

• Perform and/or coordinate with the programming team the production of the definitions, documentation and review of derived variables, as well as the quality control plan.

• Perform and/or coordinate with study programmer the production of biomarker statistical analyses (eg. ROC curve, survival analysis, linear mixed models). Review and examine statistical data distributions/properties.

• Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.

• Propose, prepare and perform exploratory biomarker data analyses, ad-hoc analyses as relevant for the study, project objectives or publication.

• Ensure productive collaborations with other functions in the aligned study team and in communicating with senior leadership.

• Represent statistics to participate in scientific or technology working groups or cross function initiatives

About you

Experience:

• (Master) or (PhD) of pharmaceutical in Data Science, Bioinformatics, Data Science and related industry experience

• Soft and technical skills:

• Good knowledge of pharmaceutical clinical development
• Good knowledge and good understanding of key statistical concepts and techniques, in particular high-dimensional statistics (eg. principal component analysis, cluster analysis, Bayesian hierarchical models, bootstrap methods, support vector machine, Lasso, non-asymptotic analysis)
• Good knowledge in handling complex biomarker data (e.g., RNAseq, scRNAseq, Olink, flow cytometry data etc.), knowledge in pathway level and network analyses is a plus.
• Able to work in departmental computing environment, do advanced statistical analyses using R&R-Shiny and possibly other languages (python, C++, …)
• Demonstrated interpersonal and communication skills and able to work in cross functional and global team setting
• Education: Master’s or Ph.D. in Data Science, Bioinformatics, Statistics, or a related field.

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